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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K123273
Device Name HOFFMANN'S CEMENT (PHOSPHATE, NORMAL)
Applicant
Temrex Corp.
300 Buffalo Ave.
Freeport,  NY  11520
Applicant Contact HABIB LAFIR
Correspondent
Temrex Corp.
300 Buffalo Ave.
Freeport,  NY  11520
Correspondent Contact HABIB LAFIR
Regulation Number872.3275
Classification Product Code
EMA  
Date Received10/19/2012
Decision Date 12/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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